Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
R-Pharm
ClinicalTrials.gov Identifier:
NCT00082433
First received: May 7, 2004
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

Condition Intervention Phase
Cancer
Breast Cancer
Drug: Ixabepilone + Capecitabine
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

Resource links provided by NLM:


Further study details as provided by R-Pharm:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: from date of randomization until death ] [ Designated as safety issue: No ]
    Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
    PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.

  • Response Rate (RR) [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
    RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants

  • Duration of Response [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
    Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.

  • Time to Response [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
    Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).

  • Treatment-Related Safety Summary [ Time Frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. ] [ Designated as safety issue: Yes ]
    Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0

  • Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) [ Time Frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment ] [ Designated as safety issue: No ]
    Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.


Enrollment: 1221
Study Start Date: November 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Ixabepilone + Capecitabine
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
Other Names:
  • IXEMPRA®
  • Epothilone
Active Comparator: B Drug: Capecitabine
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
  • Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.
  • Patients may not have any history of brain and/or leptomeningeal metastases.
  • Patients may not have Grade 2 or worse neuropathy at the time of study entry.
  • Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082433

  Show 189 Study Locations
Sponsors and Collaborators
R-Pharm
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00082433     History of Changes
Other Study ID Numbers: CA163-048 
Study First Received: May 7, 2004
Results First Received: May 1, 2009
Last Updated: February 9, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Epothilones
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 30, 2016